TH9507 in Patients With HIV-Associated Lipodystrophy

November 26, 2013 updated by: Theratechnologies

A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg Dose of TH9507, a Growth Hormone Releasing Factor Analog, in HIV Patients With Excess of Abdominal Fat Accumulation

HIV lipodystrophy affects a significant proportion of patients treated with combination antiretroviral therapy (ART) and is characterized by excess visceral fat accumulation and loss of extremity and subcutaneous fat, in association with dyslipidemia and insulin resistance. Data from a previous randomized, placebo-controlled trial demonstrated that daily administration of 2mg TH9507, a growth hormone releasing factor (GRF), to HIV patients with an excess of abdominal fat accumulation for 12 weeks resulted in decreases in visceral adipose tissue (VAT) and trunk fat, with no significant changes in limb fat and subcutaneous adipose tissue (SAT). This study is aimed at further assessing the efficacy and safety of 2 mg TH9507 in a larger population of HIV patients treated with ART and experiencing an excess of abdominal fat accumulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

412

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Southern Alberta Clinic
    • British Columbia
      • Vancouver, British Columbia, Canada
        • St-Paul's Hospital
    • Ontario
      • Toronto, Ontario, Canada
        • Sunnybrook and Women College Health Sciences Centre
      • Windsor, Ontario, Canada
        • Windsor Regional Hospital
    • Quebec
      • Montreal, Quebec, Canada
        • Clinique médicale l'Actuel
      • Montreal, Quebec, Canada
        • Clinique Medicale du Quartier Latin
      • Montreal, Quebec, Canada
        • Montreal General Hospital
  • United States
    • California
      • Los Angeles, California, United States
        • UCLA School of Medicine
      • Palm Springs, California, United States
        • Office of Dr. Michael Somero
      • San Diego, California, United States
        • Ucsd Medical Center
      • San Francisco, California, United States
        • Kaiser Permanente
      • West Hollywood, California, United States
        • AIDS Research Alliance
    • District of Columbia
      • Washington, District of Columbia, United States
        • Capital Medical Associates
    • Florida
      • Bradenton, Florida, United States
        • Bach & Godofsky
      • Ft. Lauderdale, Florida, United States
        • Office of Dr. Gary Richmond
      • Miami, Florida, United States
        • Care Resource Miami
      • Orlando, Florida, United States
        • Orlando Immunology Center
      • Sarasota, Florida, United States
        • Infectious Disease Associates
      • Vero Beach, Florida, United States
        • Treasure Coast Infectious Disease Consultant (TDIDC)
    • Georgia
      • Atlanta, Georgia, United States
        • AIDS Research Consortium Atlanta (ARCA)
    • Illinois
      • Chicago, Illinois, United States
        • Rush University Medical Center
      • Chicago, Illinois, United States
        • Northern Healthcare
    • Indiana
      • Indianapolis, Indiana, United States
        • Indiana University Department of Medicine
    • Maryland
      • Baltimore, Maryland, United States
        • Johns Hopkins University School of Medicine
      • Baltimore, Maryland, United States
        • Institute of Human Virology
    • Massachusetts
      • Boston, Massachusetts, United States
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States
        • Tufts University School of Medicine
      • Boston, Massachusetts, United States
        • Community Research Initiative of New England
      • Springfield, Massachusetts, United States
        • Community Research Initiative of New England (CRI West)
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Hennepin County Medical Centre
    • New York
      • New York, New York, United States
        • AIDS Community Research Initiative of America
      • New York, New York, United States
        • Bellevue Hospital Center New York University
      • New York, New York, United States
        • St Luke's Roosevelt Hospital Centre
      • New York, New York, United States
        • St Vincent Catholic Medical Centre
    • Ohio
      • Cincinnati, Ohio, United States
        • University of Cincinnati Medical Center
    • Oregon
      • Portland, Oregon, United States
        • Fanno Creek Clinic, LLC
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Drexel University College of Medicine
    • Texas
      • Austin, Texas, United States
        • Central Texas Clinical Research
      • Dallas, Texas, United States
        • Dallas VA Medical Centre
      • Houston, Texas, United States
        • The University of Texas Medical School
    • Virginia
      • Annandale, Virginia, United States
        • Infectious Disease Physicians Inc.
    • Washington
      • Seattle, Washington, United States
        • Swedish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ages 18 to 65 years inclusive
  • HIV positive; CD4 cell counts >100 cells/mm3; viral load <10,000 copies/mL (stable for 8 weeks)
  • On stable ART regimen for at least 8 weeks prior to randomization

  • Have evidence of abdominal fat accumulation defined by the following anthropometric cut off values:

    • For males: waist circumference > 95 cm and waist to hip ratio > 0.94;
    • For females: waist circumference > 94 cm and waist to hip ratio > 0.88.
  • Females of childbearing potential not pregnant or lactating; normal mammography within 6 months of study.
  • Signed informed consent

Exclusion Criteria:

  • Body mass index < 20 kg/m2
  • Opportunistic infection; HIV-related disease within 3 months of study.
  • History of malignancy; active neoplasm.
  • Prostate-specific antigen (PSA) >5 ng/mL at screening
  • Hypopituitarism; history of pituitary tumor/surgery; head irradiation; head trauma that has affected the somatotropic axis.
  • Untreated hypothyroidism
  • Type 1 diabetics and type 2 diabetics on oral hypoglycemic or insulin sensitizing agent within 6 months of study
  • ALT or AST > 3 x ULN; serum creatinine > 133 mmol/L (1.5 mg/dL); hemoglobin more than 20 g/L below LLN; fasting blood glucose > 8.33 mmol/L (150 mg/dL); fasting triglycerides > 11.3 mmol/L (0.99 g/dL).
  • Untreated hypertension
  • Change in anti-hyperlipemic regimen within 3 months prior to study
  • Change in testosterone regimen and/or supraphysiological dose of testosterone
  • Estrogen therapy
  • Anoretics/anorexigenics or anti-obesity agents within 3 months of study
  • Growth hormone (GH); GH secretagogues; growth hormone releasing factor (GRF) products; IGF-1; or IGFBP-3 within 6 months of study.
  • Drug or alcohol dependence or use of methadone within 6 months of study entry
  • Participation in a clinical trial with any investigational drug/device within 30 days of screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Visceral adipose tissue (VAT)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theratechnologies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

July 20, 2005

First Submitted That Met QC Criteria

July 20, 2005

First Posted (Estimate)

July 22, 2005

Study Record Updates

Last Update Posted (Estimate)

November 27, 2013

Last Update Submitted That Met QC Criteria

November 26, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TH9507/III/LIPO/010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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